ATS Pulmonary Function Laboratory Manual

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7. Test Procedures (Pre-Test and Test) —instructions on patient identification, and detailed step-by-step instructions on the procedure, written using the imperative form (e.g., seal the plethysmograph door); keep these instructions free of extraneous matter (e.g., explanations or justifications) 8. Review of Test Results (Post-Test) —policy on final review of test results before entry into patient chart of institution information system 9. Reporting of Test Results (Post-Test) —instructions on reporting format (e.g., rounding off procedures, averaging or highest value, and reference values) 10. Procedure Notes —information concerning the procedure not included in the purpose/principle section, reasons for special precautions, possible sources of error, helpful hints, pitfalls, clinical situations that can influence the validity of test results, and acceptable turnaround time 11. References —manufacturer’s product literature, textbooks, standards and guideline publications, and other pertinent publications This publication contains templates for commonly used procedures performed in PF laboratories. The templates are written in the format shown above, but the exact wording can be altered to meet specific needs. We have made a strong effort to base the material on published guidelines and standardization statements. In cases in which such guidelines are not available, we have relied on important and pertinent publications. Because we cannot foresee every situation, we encourage that each laboratory customize each chapter as needed. However, the ATS is not responsible for any untoward responses, and laboratories and institutions must take full responsibil- ity for these procedures. The administrative or nontechnical policies and procedures can be kept in a separate manual. However, this publication has included a few of them with the technical procedures, using the same basic style. Other adminis- tration policies and procedures that a laboratory might consider include: attendance and punctuality, dress code, meals and rest periods, staffing plan, charging for tests, scheduling of procedures, patient incidents, smoking, and exposure control plan. Reviews and Updates of Procedure Manual All technical procedures should be reviewed at least annually, and whenever a change is made in methodology and/ or instrumentation. At the time of review, the procedure can be reapproved as written, revised, or retired. The reviewer(s), who will vary according to administrative structure, should have firsthand knowledge of the procedure and be the director, manager, qualified supervisor, or a delegated committee. However, the medical director should oversee the process and is ultimately responsible for the procedure. The review should be documented, with the reviewer signing and dating the appropriate section. If there are multiple copies of the procedure, all copies must be reviewed as described. Obsolete or superseded procedures should be clearly marked as “retired” and stored in a retired file or retired section of the manual. Retired procedures should be kept for a minimum of 2 years. These review and update recommendations also apply to electronic manuals. Only approved procedures should be available. If the manual is accessible electronically, new or edited material—or material under development— should not be accessible.

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